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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Patch testing to FD&C and D&C dyes
Author:
Guin JD.
Year:
2003
Bibliographic source:
Contact Dermatitis, 2003: 49: 217–218

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The sensitization potential of D & C Red No. 6 (CAS no: 5858-81-1) was examined to determine the allergic contact dermatitis caused by the chemical via performing patch test on humans.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Ldisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate/ Lithol Rubine B
- Molecular formula (if other than submission substance): C18H14N2O6S.2Na
- Molecular weight (if other than submission substance): 432.38 g/mole
- Substance type: Organic
Specific details on test material used for the study:
Name of the test chemical: disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate
Common Name: D & C Red No. 6
Molecular Formula: C18H12N2Na2O6S
Molecular Weight: 430.3468 g/mol
InChI: 1S/C18H14N2O6S.2Na/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);;/q;2*+1/p-2/b20-19+;;
Substance Type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:
other: hunan
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: epicutaneous
Vehicle:
water
Concentration / amount:
20%
Day(s)/duration:
7 days
Adequacy of induction:
not specified
Challenge
Route:
other: epicutaneous
Vehicle:
water
Concentration / amount:
20%
Day(s)/duration:
7 days
Adequacy of challenge:
not specified
No. of animals per dose:
15 patients
Details on study design:
The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.
The reactions of the patients were graded as ?+. + and ++ categories.
Challenge controls:
no data availble
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
168
Group:
test group
Dose level:
20%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
None of the treated patients showed allergic contact dermatitis.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
None of the treated patients showed allergic contact dermatitis.

Any other information on results incl. tables

Table 1:  Patch test results

 

Chemical

No of patients tested

?+

+

++

D & C Red No. 6 (20% aq.)

15

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
No patients showed any signs of sensitization. Thus the chemical D & C Red No. 6 (CAS no: 5858-81-1) can be considered as non sensitizer to human skin.
Executive summary:

The sensitization potential ofD & C Red No. 6 (CAS no: 5858-81-1)was examined to determine the allergic contact dermatitis caused by the chemical via performing patch test on human patients.

 

The dye was applied on15patients in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.

 

 None of the treated patients showedany signs ofallergic contact dermatitis. Hencethe chemical D & C Red No. 6 (CAS no: 5858-81-1) can be considered as non sensitizer to human skin.